Rappel de Device Recall Medtronic

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic CardioVascular.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    46353
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0689-2008
  • Date de mise en oeuvre de l'événement
    2007-12-10
  • Date de publication de l'événement
    2008-04-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2008-07-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Endovascular Stent - Product Code MIH
  • Cause
    Sterility compromised: device sterility may be compromised as evidenced by a loss of outer package integrity.
  • Action
    Medtronic sent Urgent Communication - Medical Device Correction Advisory Notice letters to all its direct consignees on 12/7/07, via Federal Express, informing them of the affected product and providing instructions on avoiding contamination of the sterile surgical field with these devices.

Device

  • Modèle / numéro de série
    All codes
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; || Model Numbers Affected: All AAAdvantage models including: || AEXC202040, IEXC121255, ILXC1212115, ILXC151585, || AEXC222240, IEXC131355, ILXC1212135, ILXC1616115, || AEXC242440, IEXC141455, ILXC121285, ILXC1616135, || AEXC262640, IEXC151555, ILXC1313115, ILXC161685, || AEXC282840, IEXC161655, ILXC1313135, ILXC1620115, || BFXC2012135, IEXC162085, ILXC131385, ILXC1620135, || BFXC2012165, IEXC181855, ILXC1414115, ILXC1818115, || BFXC2213135, IEXC182285, ILXC1414135, ILXC1818135, || BFXC2213165, IEXC182485, ILXC141485, ILXC181885, || BFXC2414135, IEXC202055, ILXC1515115, ILXC1822115, || BFXC2414165, ILXC1515135, ILXC1822135, || BFXC2615135, ILXC1824115, || BFXC2615165, ILXC1824135, || BFXC2816135, ILXC2020115, || BFXC2816165, ILXC2020135, || ILXC202085; || Product is manufactured and distributed by Medtronic, Inc., Santa Rosa, CA 95403
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Medtronic CardioVascular, 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA